Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment

Lipoprotein Lipase Deficiency Clinical Trial

Official title:

Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656095
• Other study ID #: 15-1412
• Secondary ID: UL1TR001082
• Status: Completed
• Start date: March 2016
• Est. completion date: March 1, 2018

Study information

• Verified date: July 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study plans to learn more about measuring Lipoprotein lipase (LPL) activity in humans. LPL is an enzyme in the breakdown of certain types of fats into smaller parts. Lipoprotein lipase deficiency (LPLD) is a very rare genetic disorder in which lipoprotein enzyme is no longer functional. This can cause conditions known as high triglycerides in the blood and inflammation of the pancreas.

Investigational medications to treat LPLD are currently being developed. In order to see if these medications are effective, it is necessary to be able to accurately measure LPL activity in humans.

LPL activity has been successfully measured in animal models after giving heparin. Heparin is a blood thinner which is approved by the FDA. It is originally used to prevent blood clots. This study will administer heparin to healthy adults through intravenous infusion (IV). Blood samples will be collected before and after the infusion to test LDL levels.

The purpose of this study is to develop a cheap, more reliable standard for assessment of LPLD in patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 39 Years

Eligibility

Inclusion Criteria:

1. male and females between ages of 20-39

Exclusion Criteria:

1. Past history of LPL deficiency

2. Hypercholesterolemia (Cholesterol >200, LDL >160, HDL <35) hypertriglyceridemia (TG>150), any familial lipid disorder

3. Diabetes mellitus (type 1 or 2)

4. Uncontrolled hypertension SBP>140, DBP>90

5. History of hemorrhagic stroke

6. Current pregnancy

7. History of major surgery, invasive procedure or trauma within the last 30 days, or planned major surgery within 30 days after participating in the study

8. Exposure to heparin (unfractionated heparin or low molecular weight heparin) within 30 days prior to screening

9. History of allergy to heparin

10. History of heparin-induced thrombocytopenia

11. Current smoking

12. Active ulcerative or angiodysplastic GI diseases

13. Thrombocytopenia or platelet disorders (Platelet count <100,000/UL)

14. Major health issues which may affect the safety of study subject, including but not limited to:

• History of chronic kidney disease (eGFR<60)

• Long term use of medications which alter lipid metabolism

• History of hepatic disease (ALT or AST more than 2 times the upper limit of normal)

• History of clotting disorders, any type of coagulation factor deficiency, or thrombocytopenia

• Chronic use of ASA, anticoagulants, platelet inhibitors

• Use of NSAIDS for more than 2 weeks prior to screening

• Anemia (hemoglobin <13 g/dL)

Related Conditions & MeSH terms

• Hyperlipoproteinemia Type I
• Lipoprotein Lipase Deficiency

Intervention

Drug:
• Heparin
Participants will be given IV heparin in order to release lipoprotein lipase from capillary endothelial cells. Blood will be drawn 10-15 minutes post-heparin administration and run through assay to determine lipoprotein lipase levels.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Lipoprotein lipase levels	Blood will be drawn after IV heparin administration and run through assay to determine lipoprotein lipase levels.	10-15 minutes post-heparin adminstration